MACROGOLS SOP


1.0  OBJECTIVE:
To lay down a procedure of analytical report for the active raw material of the Macrogols from the Pharmacopoeial specifications.
2.0  SCOPE:
This SOP shall be applicable in Q.C laboratory.
3.0  RESPONSIBILITY:
3.1  Q.C Analysts.
4.0  ACCOUNTABILITY:
4.1  Q.C Manager.
5.0  PROCEDURE:
5.1  Characters:
5.1.1        Appearance:
5.1.1.1  White or almost white solid with a waxy or paraffin-like appearance.
5.1.2        Solubility:
5.1.2.1  Material and equipment:
5.1.2.1.1        Glassware (5 test tubes, 1 spatula, 1 pipette).
5.1.2.1.2        alcohol
5.1.2.1.3        Methylene chloride.
5.1.2.1.4        Fatty oils.
5.1.2.1.5        Mineral oils.
5.1.2.1.6        Purified water.
5.1.2.2  Sample:
5.1.2.2.1        Small quantity.
5.1.2.3  Method:
5.1.2.3.1        Take 5 test tubes and add small quantity of sample for testing solubility according to B.P specifications.
5.1.2.3.2        Add purified water in test tube 1 and observe.
5.1.2.3.3        Add methylene chloride in test tube 2 and observe.
5.1.2.3.4        Add alcohol in test tube 3 and observe.
5.1.2.3.5        Add fatty oil in test tube 4 and observe.
5.1.2.3.6        Add mineral oil in test tube 5 and observe.
5.1.2.4  Observations:
5.1.2.4.1        The sample in test tube 1 & 2 containing with purified water & methylene chloride is very soluble, respectively.
5.1.2.4.2        The sample in test tube 3 containing with alcohol is very slightly soluble.
5.1.2.4.3        The sample in test tube 4 & 5 containing with fatty oils and mineral oils are practically insoluble.
5.2  Identification tests:
5.2.1         
5.2.1.1  Material and equipment:
5.2.1.1.1        Glassware (1 stoppered test tube, 1 spatula).
5.2.1.1.2        0.5ml of sulfuric acid.
5.2.1.1.3        1.0ml of mercuric chloride solution.
5.2.1.2  Sample:
5.2.1.2.1        1.0g.
5.2.1.3  Method:
5.2.1.3.1        Take a test tube and add 1.0g of sample in it.
5.2.1.3.2        Add 0.5ml of sulfuric acid, close the test tube with a stopper fitted with a bent delivery tube.
5.2.1.3.3        Heat it on Bunsen burner until fumes are evolved.
5.2.1.3.4        Collect the fumes via the delivery tube into another test tube containing with 1.0ml of mercuric chloride solution R.
5.2.1.3.5        Observe the changes.
5.2.1.4  Observations:
5.2.1.4.1        An abundant, white, crystalline ppt is formed.
5.2.2         
5.2.2.1  Material and equipment:
5.2.2.1.1        Glassware (1 stoppered test tube, 1 spatula).
5.2.2.1.2        0.1g of potassium thiocyanate.
5.2.2.1.3        0.1g of cobalt nitrate.
5.2.2.1.4        5.0ml of methylene chloride.
5.2.2.2  Sample:
5.2.2.2.1        0.1g.
5.2.2.3  Method:
5.2.2.3.1        Take a test tube and add 0.1g of sample in it.
5.2.2.3.2        Add 0.1g of potassium thiocyanate and 0.1g of cobalt nitrate. Mix it thoroughly by using glass rod.
5.2.2.3.3        Add 5.0ml of methylene chloride and shake.
5.2.2.3.4        Observe the changes.
5.2.2.4  Observations:
5.2.2.4.1        The liquid phase becomes blue.
6.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

7.0  REFERENCES:
7.1  The British Pharmacopoeia. Vol II., Official Monograph / Macrogols: 2015, pp. 146-149.
8.0  ANNEXURES:
8.1  Not Applicable.

9.0  ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
B.P
British pharmacopoeia
mg
Milligram
ml
Milliliter
g
Grams
Vol
Volume
QCA
Quality control active ingredient
F
Format
%
Percentage
B.P
British pharmacopoeia
ppt
Precipitates


No comments:

Post a Comment